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Surfactant therapies for pediatric and neonatal ARDS: ESPNIC expert consensus opinion for future research steps
Daniele De Luca1,2, Paola Cogo3, Martin C Kneyber4,5
1Division of Pediatrics and Neonatal Critical Care, "A.Béclère" Medical Centre, Paris Saclay University Hospitals, APHP, 157 Rue de la Porte de Trivaux, 92140, Clamart (Paris-IDF), France. dm.deluca@icloud.com.
Insights
Surfactant therapy shows promise for pediatric (PARDS) and neonatal (NARDS) acute respiratory distress syndrome, but past trials had conflicting results. New expert consensus guides future research for improved treatments.
Area of Science:
- Pediatric and neonatal critical care medicine
- Respiratory physiology and pathophysiology
- Pharmacological interventions in critical illness
Background:
- Pediatric acute respiratory distress syndrome (PARDS) and neonatal acute respiratory distress syndrome (NARDS) have distinct characteristics and definitions.
- Previous surfactant trials in children and neonates yielded conflicting results due to heterogeneous study designs and lack of pathobiological understanding.
- Existing clinical and preclinical data warrant further investigation into surfactant therapies for PARDS and NARDS.
Purpose of the Study:
- To review existing clinical and preclinical data on surfactant use in PARDS and NARDS.
- To establish an expert consensus to guide future research in this field.
- To advance the understanding and treatment of pediatric and neonatal acute respiratory distress syndrome.
Main Methods:
- Comprehensive review of eight trials in children and ten trials in neonates investigating surfactant for ARDS.
- Analysis of study designs, patient characteristics, surfactant types, and administration strategies.
- Formation of an expert consensus based on available data and pathobiological knowledge.
Main Results:
- Improvements in oxygenation were observed in 7/8 pediatric and 7/10 neonatal trials.
- Mortality improvements were noted in 3/8 pediatric and 1/10 neonatal trials.
- Significant heterogeneity existed across trials, impacting result interpretation.
Conclusions:
- Sufficient data support targeted surfactant research for PARDS and NARDS, adhering to current definitions and pathobiology.
- PARDS and NARDS should be studied as syndromes, considering key characteristics like origin, severity, and age.
- Future trials should prioritize explanatory designs and select outcomes tailored to specific trial parameters and patient populations.
Abstract:
Pediatric (PARDS) and neonatal (NARDS) acute respiratory distress syndrome have different age-specific characteristics and definitions. Trials on surfactant for ARDS in children and neonates have been performed well before the PARDS and NARDS definitions and yielded conflicting results. This is mainly due to heterogeneity in study design reflecting historic lack of pathobiology knowledge. We reviewed the available clinical and preclinical data to create an expert consensus aiming to inform future research steps and advance the knowledge in this area. Eight trials investigated the use of surfactant for ARDS in children and ten in neonates, respectively. There were improvements in oxygenation (7/8 trials in children, 7/10 in neonates) and mortality (3/8 trials in children, 1/10 in neonates) improved. Trials were heterogeneous for patients' characteristics, surfactant type and administration strategy. Key pathobiological concepts were missed in study design. Consensus with strong agreement was reached on four statements: 1. There are sufficient preclinical and clinical data to support targeted research on surfactant therapies for PARDS and NARDS. Studies should be performed according to the currently available definitions and considering recent pathobiology knowledge. 2. PARDS and NARDS should be considered as syndromes and should be pre-clinically studied according to key characteristics, such as direct or indirect (primary or secondary) nature, clinical severity, infectious or non-infectious origin or patients' age. 3. Explanatory should be preferred over pragmatic design for future trials on PARDS and NARDS. 4. Different clinical outcomes need to be chosen for PARDS and NARDS, according to the trial phase and design, trigger type, severity class and/or surfactant treatment policy. We advocate for further well-designed preclinical and clinical studies to investigate the use of surfactant for PARDS and NARDS following these principles.
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